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Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial

INTRODUCTION: Fluticasone furoate (FF)/vilanterol (VI) dry powder inhaler (DPI) is the only once-daily maintenance inhaled corticosteroid (ICS)/long-acting β2 adrenergic agonist (LABA) combination for asthma. We aimed to compare the clinical effects of once-daily FF/VI and twice-daily budesonide (BU...

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Autores principales: Furuhashi, Kazuki, Fujisawa, Tomoyuki, Hashimoto, Dai, Kamiya, Yousuke, Yasui, Hideki, Karayama, Masato, Suzuki, Yuzo, Hozumi, Hironao, Enomoto, Noriyuki, Nakamura, Yutaro, Inui, Naoki, Suda, Takafumi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756272/
https://www.ncbi.nlm.nih.gov/pubmed/31571932
http://dx.doi.org/10.2147/JAA.S223093
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author Furuhashi, Kazuki
Fujisawa, Tomoyuki
Hashimoto, Dai
Kamiya, Yousuke
Yasui, Hideki
Karayama, Masato
Suzuki, Yuzo
Hozumi, Hironao
Enomoto, Noriyuki
Nakamura, Yutaro
Inui, Naoki
Suda, Takafumi
author_facet Furuhashi, Kazuki
Fujisawa, Tomoyuki
Hashimoto, Dai
Kamiya, Yousuke
Yasui, Hideki
Karayama, Masato
Suzuki, Yuzo
Hozumi, Hironao
Enomoto, Noriyuki
Nakamura, Yutaro
Inui, Naoki
Suda, Takafumi
author_sort Furuhashi, Kazuki
collection PubMed
description INTRODUCTION: Fluticasone furoate (FF)/vilanterol (VI) dry powder inhaler (DPI) is the only once-daily maintenance inhaled corticosteroid (ICS)/long-acting β2 adrenergic agonist (LABA) combination for asthma. We aimed to compare the clinical effects of once-daily FF/VI and twice-daily budesonide (BUD)/formoterol (FM) DPI in patients with controlled stable asthma. METHODS: We performed a randomized crossover trial in which stable asthmatic patients controlled on ICS/LABA received 8 weeks of FF/VI (100/25 μg 1 puff once-daily) or BUD/FM (160/4.5 μg 2 puffs twice-daily) DPI treatment. After a 4–8-week washout period, patients received another crossover treatment for 8 weeks. We assessed pulmonary function, the 5-item version asthma control questionnaire (ACQ5), the asthma control test (ACT), and fractional exhaled nitric oxide (FeNO) at baseline and after 8 weeks of treatment (week 8). As the primary outcome was change in force expiratory volume in 1 s (FEV(1)) between baseline and week 8, we evaluated the incidence of asthma exacerbation and adherence barrier questionnaire (Ask-12) at week 8. RESULTS: Twenty-three patients were initially enrolled in this study; however, one patient had to be excluded. The FF/VI DPI treatment group showed a similar magnitude of change in FEV(1) between baseline and week 8 as the BUD/FM DPI treatment group. In addition, there were no significant differences in pulmonary function tests, ACQ5 scores, ACT scores, and FeNO between baseline and week 8 in both groups. Although the incidence of exacerbation did not differ between groups, the Ask-12 score in the FF/VI DPI group was significantly lower than that in the BUD/FM DPI group. CONCLUSIONS: The present study indicates that once-daily FF/VI DPI is not inferior to twice-daily BUD/FM DPI in clinical effect and more likely to improve inconvenience and forgetfulness in inhalation adherence barriers for stable asthma control therapy. Once-daily FF/VI DPI may be an effective alternative for asthma maintenance treatment.
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spelling pubmed-67562722019-09-30 Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial Furuhashi, Kazuki Fujisawa, Tomoyuki Hashimoto, Dai Kamiya, Yousuke Yasui, Hideki Karayama, Masato Suzuki, Yuzo Hozumi, Hironao Enomoto, Noriyuki Nakamura, Yutaro Inui, Naoki Suda, Takafumi J Asthma Allergy Clinical Trial Report INTRODUCTION: Fluticasone furoate (FF)/vilanterol (VI) dry powder inhaler (DPI) is the only once-daily maintenance inhaled corticosteroid (ICS)/long-acting β2 adrenergic agonist (LABA) combination for asthma. We aimed to compare the clinical effects of once-daily FF/VI and twice-daily budesonide (BUD)/formoterol (FM) DPI in patients with controlled stable asthma. METHODS: We performed a randomized crossover trial in which stable asthmatic patients controlled on ICS/LABA received 8 weeks of FF/VI (100/25 μg 1 puff once-daily) or BUD/FM (160/4.5 μg 2 puffs twice-daily) DPI treatment. After a 4–8-week washout period, patients received another crossover treatment for 8 weeks. We assessed pulmonary function, the 5-item version asthma control questionnaire (ACQ5), the asthma control test (ACT), and fractional exhaled nitric oxide (FeNO) at baseline and after 8 weeks of treatment (week 8). As the primary outcome was change in force expiratory volume in 1 s (FEV(1)) between baseline and week 8, we evaluated the incidence of asthma exacerbation and adherence barrier questionnaire (Ask-12) at week 8. RESULTS: Twenty-three patients were initially enrolled in this study; however, one patient had to be excluded. The FF/VI DPI treatment group showed a similar magnitude of change in FEV(1) between baseline and week 8 as the BUD/FM DPI treatment group. In addition, there were no significant differences in pulmonary function tests, ACQ5 scores, ACT scores, and FeNO between baseline and week 8 in both groups. Although the incidence of exacerbation did not differ between groups, the Ask-12 score in the FF/VI DPI group was significantly lower than that in the BUD/FM DPI group. CONCLUSIONS: The present study indicates that once-daily FF/VI DPI is not inferior to twice-daily BUD/FM DPI in clinical effect and more likely to improve inconvenience and forgetfulness in inhalation adherence barriers for stable asthma control therapy. Once-daily FF/VI DPI may be an effective alternative for asthma maintenance treatment. Dove 2019-09-17 /pmc/articles/PMC6756272/ /pubmed/31571932 http://dx.doi.org/10.2147/JAA.S223093 Text en © 2019 Furuhashi et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Clinical Trial Report
Furuhashi, Kazuki
Fujisawa, Tomoyuki
Hashimoto, Dai
Kamiya, Yousuke
Yasui, Hideki
Karayama, Masato
Suzuki, Yuzo
Hozumi, Hironao
Enomoto, Noriyuki
Nakamura, Yutaro
Inui, Naoki
Suda, Takafumi
Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title_full Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title_fullStr Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title_full_unstemmed Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title_short Once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
title_sort once-daily fluticasone furoate/vilanterol combination versus twice-daily budesonide/formoterol combination in the treatment of controlled stable asthma: a randomized crossover trial
topic Clinical Trial Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6756272/
https://www.ncbi.nlm.nih.gov/pubmed/31571932
http://dx.doi.org/10.2147/JAA.S223093
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